BANGALORE, India--(BUSINESS WIRE)--L&T Technology Services Limited (LTTS) (BSE: 540115, NSE: LTTS), a leading global pure-play engineering services company, has announced a collaboration with NVIDIA ...
Medical Device Network on MSN
FDA announces regulatory exemptions for 'non-medical grade' devices
FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less ...
There has been a surge in academic and business interest in software as a medical device (SaMD). It enables medical professionals to streamline existing medical practices and make innovative medical ...
A monthly overview of things you need to know as an architect or aspiring architect. Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up to receive our free e-Newsbulletins Some states have laws and ethical rules regarding solicitation and ...
The Food and Drug Administration has finalized a regulation that provides a less-burdensome path to market for certain hardware and software products used with medical devices, according to an FDA ...
Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...
On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). 1 The ...
In August 2013, the FDA made news when it issued cybersecurity guidance for medical devices. But several years earlier, government officials recognized the risk: Soon after the FDA made its ...
Medical device manufacturing has always been a balancing act between innovation and regulation. For companies specializing in plastic components—whether injection-molded housings, fluid connectors, ...
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